US legislators have attacked colleagues for holding a hearing to discuss generic competition to biologic drugs without any scientific experts being called to give evidence.
The hearing was held last Thursday by the House Energy and Commerce Subcommittee on Health to discuss the r
eport published the day before by the Federal Trade Commission (FTC), which concluded that the makers of pioneer biologic drugs do not need the 12-14 years’ brand exclusivity which they claim is necessary, nor do producers of “follow-on” biologics (FOBs) need additional incentives such as 180
-day market exclusivity, which they also say they need.
The only witness called to the hearing was FTC Commissioner Pamela Jones Harbour. Welcoming her, the subcommittee’s chairman, Representative Frank Pallone Jr, said: “the FTC has decades of expertise in this area and I value their ob
jective and comprehensive analysis.”
Rep Henry Waxman, who chairs the Committee on Energy and Commerce, also spoke at the hearing, and accused the industry of engaging in “a massive and expensive lobbying campaign to convince the members of this Committee that the supply of life-saving dr
ugs will dry up if they don’t get triple the monopoly protection available to all other drugs.”
To support its “extraordinary request for 12 or even 14 years” of exclusivity, the industry “has blanketed Capitol Hill” with its arguments that its patents are much weaker than drug pate
nts and will not block competition from FOBs, and also that it takes 12-16 years for biotech drugs to break even “so that’s the period of exclusivity they need.”
“I have seen little or no persuasive evidence to support these arguments,” said Rep Waxman, who is sponsor of a bill which
would give innovator biologics makers just five years’ market exclusivity.
But panel member Democrat Anna Eshoo, who represents Palo Alto in California, said she was “puzzled and somewhat disappointed” that no experts had been called to give evidence to the hearing on the safety and effectiveness of FOBs, while Republican Marsha Blackburn and Democrat Tammy Baldwin, who represent areas of Tennessee and Wisconsin, respectively, which are homes to innovator biotechnology companies, expressed concern about the ability of these firms to recoup their R&D investments if FOBs were permitted to come speedily to market.
The process adopted by the panel to deal with this issue did not “reflect well on the most distinguished committee and subcommittee of the House,” Rep Eshoo told Rep Pallone, but he replied that Commissioner Harbour had been called to testify because she was “the only objective third-party who has dealt with the issue. All we have heard from are people with a financial stake, either companies that want to protect the market or companies that want in,” he told her.
Reaction to FTC’s findings
Responding to the FTC report, Michael Keeley, partner in the Antitrust Group of Axinn, Veltrop & Harkrider LLP in New York, told Pharma Times that it “reveals a great level of dissatisfaction on the part of the FTC with how Hatch-Waxman has operated. The FTC clearly believes that Hatch-Waxman has facilitated so-called reverse payment arrangements between brands and generics in small molecule drugs. The FTC in its biologics report tries to make the case that biologics should not be subject to a Hatch-Waxman type regime to avoid similar opportunities for reverse payments and other types of conduct that FTC argues is anti-competitive,” he said.
Jeff Joseph, vice president of communications at the Biotechnology Industry Association (BIO), said the study’s isummary conclusions “are based upon fundamentally flawed or highly selective assumptions, an exceedingly narrow policy perspective and a lack of true understanding of the necessary conditions to drive future biomedical breakthroughs. The report appears to minimize greatly the impact on innovation that would occur under a new paradigm in which biosimilar competitors would be able to take a free ride off the massive R&D investment made by the initial innovators.”
Kathleen Jaeger, chief executive of the Generic Pharmaceutical Association (GPhA), said the report was “yet another endorsement of the need to move forward on passage of legislation that brings affordable biogenerics to patients sooner rather than later.”
* Rep Ishoo is cosponsor of the Pathway for Biosimilars Act (HR 1548) which would give innovator firms 12 years’ exclusivity and preserve “incentives to innovate.” Fellow sponsor Democrat Jay Inslee, who represents a Seattle-area district with a strong biotechnology sector, said that, through the bill, a pathway to lower-cost copies of biotech drugs can be created “without sacrificing safety or eliminating incentives to create breakthrough medicines.”
